Various devices exist for the testing of sealed packages. These techniques include methods of optical inspection via cameras or lasers, as well as the analysis of signals from force or pressure gauges to make a determination of seal quality. The variation of force over time during the sealing process is referred to as a force profile. Various systems exist which ensure seal integrity has been ascertained by comparing the force profile used in sealing a container to that of a reference signal. This has the disadvantage of requiring a known sample to define the sealing process. Furthermore, it can be difficult to describe in numbers the various manual adjustments required in the set-up of an automatic container-sealing machine. The nature of the pharmaceutical industry warrants manufacturing processes that can be validated. The manufacturing process must be reproducible, and consistently perform as intended. Therefore, there exists a need for a method, apparatus, and system to define a container-sealing process in a manner described quantitatively, and with a high degree of repeatability.
The disclosure of U.S. Pat. No. 4,511,044 is incorporated by reference herein, to the extent not inconsistent herewith.